online ethics system principal supervisor user guide

User Guide

Human Research Ethics Application

And

Review System

Supervisor Guide Version 4

Research and Innovation Services

For further information or assistance please contact the Research Ethics Office:

e-mail [email protected], ph. 8302 6330

This is an official document of the University of South Australia for internal use only. The document has been

prepared by Research and Innovation Services for web use and will be maintained on a regular basis. To ensure

you have the most recent version it is advised that you access this document from its original location and do

not keep local copies. The reader should be aware that this document is for the University of South Australia’s

employees’ and students’ information only and nothing contained in this information should be construed as an

offer of service by the University of South Australia, form part of the terms of any agreement, or be legally binding

on the University of South Australia.

Copyright University of South Australia all rights reserved.

mailto:[email protected],

Last Updated: December 2019 Online Ethics System: Supervisor User Guide

CONTENTS OVERVIEW: HUMAN RESEARCH ETHICS APPLICATION AND REVIEW SYSTEM .............................................................................3

1.0 GETTING STARTED ............................................................................................................................................................................................4 1.1 Logging In ............................................................................................................................................................ 4

1.2 Locating Applications for Review ........................................................................................................................ 5

2.0 REVIEWING THE APPLICATION ...................................................................................................................................................................7 2.1 Navigating the Application .................................................................................................................................. 7

2.2 Viewing Attachments .......................................................................................................................................... 8

3.0 ADDING AND DELETING COMMENTS .................................................................................................................................................. 10 3.1 Adding Page Level Comments ........................................................................................................................... 10

3.2 Deleting Page Level Comments ......................................................................................................................... 11

3.3 Adding Form Comments ................................................................................................................................... 12

3.4 Deleting Form Comments ................................................................................................................................. 14

4.0 REVIEWING RESPONSES TO COMMENTS ............................................................................................................................................. 15 4.1 Reviewing Page Level Comments ...................................................................................................................... 15

4.2 Reviewing Form Comments .............................................................................................................................. 16

4.3 Viewing a PDF or HTML Copy of the Comments ............................................................................................... 17

5.0 VIEWING A PDF OR HTML COPY OF THE APPLICATION .............................................................................................................. 19

6.0 SUBMITTING/REVERTING APPLICATION ............................................................................................................................................... 21 6.1 Reverting the Application ................................................................................................................................. 21

6.2 Submitting the Application ............................................................................................................................... 21

7.0 EMAIL NOTIFICATIONS ................................................................................................................................................................................ 22

8.0 AMENDING AN APPROVED APPLICATION .......................................................................................................................................... 22

9.0 TROUBLESHOOTING ..................................................................................................................................................................................... 22

APPENDIX .................................................................................................................................................................................................................. 23 APPLICATION STATUS.............................................................................................................................................. 23

COMMON TERMS.................................................................................................................................................... 25

TOOLBAR ................................................................................................................................................................. 25

COMMENT FLAGS ................................................................................................................................................... 26


OVERVIEW: HUMAN RESEARCH ETHICS APPLICATION AND

REVIEW SYSTEM

All staff and students at the University of South Australia (UniSA) who wish to undertake a research project

involving humans (including direct collection of data, accessing data from databases and/or collection of human

tissues/samples etc.) must apply for ethics approval from the UniSA Human Research Ethics Committee (HREC)

using the Human Research Ethics Application and Review System (the System).

Researchers must be familiar with the following documents before using the System:

a. the National Statement on Ethical Conduct in Human Research

(https://nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-

updated-2018)

b. the Australian Code for the Responsible Conduct of Research

(https://nhmrc.gov.au/about-us/publications/australian-code-responsible-conduct-research-2018).

The University’s Human Research Ethics webpages provide further information on the ethics application and

review process: https://i.unisa.edu.au/staff/research/research-ethics/human-research-ethics

Note: The images displayed in this user guide were captured using fictitious examples of a human ethics

Application and do not contain information or details of actual Applications.

https://nhmrc.gov.au/about-us/publications/australian-code-responsible-conduct-research-2018

https://i.unisa.edu.au/staff/research/research-ethics/human-research-ethics


1.0 GETTING STARTED

1.1 Logging In

Navigation: https://rme.unisa.edu.au/RME6/

Action: Enter your UniSA network User Name and Password and click the Login button.

Result: User is logged into the system and the Home page is displayed.

https://rme.unisa.edu.au/RME6/


1.2 Locating Applications for Review

Navigation:

Select ‘Ethics Applications’ (under ‘Online Human Research Ethics’)

Action: Click on ‘My Applications’

Result: Applications available for supervisor review are displayed.

Note: Applications are grouped according to their status.


Action: Click on the Application ID to open the application.

Result: The Application is displayed

Note: The Application will be forwarded to all Supervisors listed on the Application by the student. However,

only the Principal Supervisor should formally review the Application. If you have received an Application in

error, revert the Application back to the Student Application and ask them to change the Supervisor (see Section

6 Submitting/Reverting application).


2.0 REVIEWING THE APPLICATION

2.1 Navigating the Application

There are four components to the application.

1. Information Area: Located at the top of the screen, the Information Area displays the Application

Title, Status and Current Workflow State.

2. Toolbar: Located under the information area. The Toolbar provides actions available to view and

comment on the application. Icon descriptions can be found in the Toolbar table (appendix).

3. Navigation Panel: Located on the left-hand side of the application, the Navigation section provides

access to sections within the application (Form tab), and available actions (Action tab). The Form tab

shows the Section Headings and Pages. The Expand and Collapse links can be used to view the whole

form. The Action tab lists the action(s) available (e.g. Submit, Withdraw).

4. Application Content: The main section of the screen, displays the application questions and

responses.


2.2 Viewing Attachments

The Attachments section allows the student to upload documents to support their Application. This includes,

but is not limited to:

A list of key references.

The research tools:

o Questionnaire(s)

o Interview/focus group questions or topics

The recruitment material:

o Participant Information Sheet(s)

o Participant Consent Form(s)

o Recruitment flyer / letter(s)

o Scripts for recruitment telephone calls. Copies of the approval letters received from organisations involved in the research and/or

organisations from which the data will be collected.

A copy of the confirmation of insurance cover from UniSA’s Insurance Officer (if required).

If the application has already been approved by another institution’s HREC: a copy of the full

application and approval letter from the other HREC.

The Reference List and Research Tools (or reasons as to why there aren’t any) are mandatory attachments.


Navigation:

In the Navigation Panel section, click the Attachments page.

Action: Click on the Document Title.

Result: The attachment will open in a new window.

Action: View the attachment and close the new window once you have finished. Repeat this step until all

attachments have been reviewed.

Note: There may be more than one page for the uploaded attachments; this is indicated by the page counter at

the bottom of the attachments table.


3.0 ADDING AND DELETING COMMENTS

There are two types of comments. They are:

Page level comments – comments specific to a page within an Application.

Form comments – overall comments about the Application.

Comments written by the Applicant or Supervisor are visible to all Investigators listed on the Application and

the Ethics Reviewers.

3.1 Adding Page Level Comments

Navigation:

Go to the page where you would like the page level comment entered.

Action: Select the Comments icon at the bottom of the page

Result: Comments dialogue is activated.

When Comments icon is selected, the following will be displayed:

Action: Select ‘Add’ (General or Action Comment) and enter text into the ‘Action Comments’ or ‘General

Comments’ window which will appear

Note 1: Select ‘General Comments’ if you do not require an immediate action or response from the applicant.

Select ‘Action Comment’ if you require a response from the applicant in order for the student to resubmit the

application.

Note 2: 4000 characters limit applies to these ‘Comments’ fields.


Action: Click the Post icon to publish comments on the specific page (or Cancel icon to remove the comment

entered)

Result: Page level comment is added. The existence of Page Comments is signified by a ‘blue flag’ (for ‘General

Comments’) or a ‘red flag’ (for ‘Action Comments’) appearing next to the page title in the Navigation Panel.

Repeat these steps to enter page comments throughout the application.

3.2 Deleting Page Level Comments

Navigation:

Go to the page where you would like to delete a page level comment.

Action: In the Toolbar, click Comments icon at the bottom of the page

Result: Page Level Comments screen is displayed.


Action: Click the Delete icon

Result: Warning message is displayed.

Action: Click OK.

Result: Page comment is deleted.

3.3 Adding Form Comments

Application-level comments can be entered from any page in the form. These comments are not linked

specifically to any page – only to the application as a whole.

Navigation:

Go to any page within the application

Action: Select the Form Comments icon from the Toolbar.

Result: Form Comments screen is displayed.


Action: Click ‘New Comment’, then choose ‘General Note’ (if you do not require an immediate action or

response from the applicant) or ‘Action Note’ (a comment that requires a response in order for the student to

resubmit). Enter text into the ‘Comments’ field then select ‘OK’ button to save the comment.

Result: Comment is added.

Repeat these steps to include additional Form Comments to the application as needed. Once you have added all

comments, select ‘Save & Close’

The existence of Form Comments is signified by a ‘blue flag’ (for ‘General Notes’) or a ‘red flag’ (for ‘Action

Notes’) appearing next to the ethics application title.


3.4 Deleting Form Comments

Navigation:

Go to any page within the application

Action: Select the Form Comments icon from the Toolbar.

Result: Form Comments screen is displayed.

Action: Click the Delete icon next to the comment you wish to delete:

Result: Warning message is displayed.

Action: Click OK.

Result: Comment is deleted.


4.0 REVIEWING RESPONSES TO COMMENTS

Once the student has amended the Application according to the Supervisor’s comments and re-submitted it for review,

the Supervisor must check whether the student has satisfactorily responded to the requirements. If so, the Supervisor

must mark all ‘Action Comments’ (page level comments) or ‘Action Notes’ (application comments in the ‘Form

Comments’ section) as having been ‘resolved’ before submitting the Application to the Ethics Compliance Officer. These

comments will appear as ‘yellow flags’ , indicating that the student has responded to the comment and now requires

‘checking’ by the supervisor accordingly.

Alternatively, if the comments have not been addressed adequately, the application must be reverted back to the student

for further changes.

NOTE: supervisors only need to ‘resolve’ their own comments – they do not need to ‘close off’ or ‘resolve’ comments

that are provided by the Ethics Compliance Officer (ECO). Supervisors are welcome to check these comments have been

actioned by the student, but they should leave the flag ‘yellow’ so that the ECO can ‘close’ their comments off accordingly.

4.1 Reviewing Page Level Comments

Navigation:

Identify the pages where the Applicant has responded to the ‘Action Comment’. These comments appear as

‘yellow flags’ next to the page title in the Navigation Panel (located on the left-hand side of the application

form)

Action: Select the relevant page and click the icon at the bottom of the page.

Result: Page Level Comments screen is displayed.

Action: Check over the response and any changes made to the relevant section/question. Once satisfied that the

‘Action Comment’ has been adequately addressed, select ‘Close’ to ‘resolve’ the comment.

Result: Confirmation Message is displayed.


Action: Click OK.

Result: Action Comments are Marked as Closed. You should see that the ‘yellow flag’ has changed colour

to a green flag to indicate that this comment has been finalised and closed-off accordingly.

Note: The supervisor and/or the Applicant needs to select the check-box ‘Show Closed’ to view the resolved

comments.

4.2 Reviewing Form Comments

Navigation:

The existence of ‘Action Notes’ in the ‘Form Comments’ section (where the Applicant has responded to the

comment) is signified by a ‘yellow flag’ appearing next to the ethics application title.

Action: Select the icon from the Toolbar.

Result: Form Comments screen is displayed


Action: Check over the response (and any changes made to the relevant section/s in the application, if applicable).

Once satisfied that the ‘Action Note’ has been adequately addressed, tick the checkbox to the left-hand side of

the comment, then select ‘Mark Selected Comments as Resolved’ to ‘resolve’ the comment.

Result: Confirmation Message is displayed – ‘Mark selected comments as resolved?’

Action: Select ‘OK’.

Result: The value of the ‘Resolved’ column for this Action Note will change to ‘Yes’.

Once all ‘Action Notes’ have been marked as having been ‘resolved’, select ‘Save & Close’

You should see that the ‘yellow flag’ next to the ethics application title will change colour to a green flag

to indicate that these comments have been finalised and closed-off accordingly.

4.3 Viewing a PDF or HTML Copy of the Comments This function allows the Applicant to generate a PDF or HTML copy of the Comments, enabling you to view all of

comments in a single document and print or save a copy.

Navigation:

Click the Reports icon from the toolbar. The following screen will open:


Action: Select Comments and either HTML or PDF.

Click OK.

Result: Document will display in a new screen. Note: if the window does not open, check your Browser

Settings to ensure that ‘Pop Ups’ are enabled.

Action: Document can be printed or saved.


5.0 VIEWING A PDF OR HTML COPY OF THE APPLICATION

This function allows the Supervisor to generate a PDF or HTML copy of the Application, enabling them to view the

entire application in a single document and print or save a copy.

Note: Attachments are not included in the PDF or HTML copy and must be opened separately.

Navigation:

Click the Reports icon from the toolbar. The following screen will open:

Action: Select Ethics Application and either HTML or PDF. Note: A summary of all comments on

the application can also be generated by selecting Comments Report.

Click OK.

Result: Document will display in a new screen. Note: if the window does not open, check your Browser

Settings to ensure that ‘Pop Ups’ are enabled.


Action: Document can be printed or saved.


6.0 SUBMITTING/REVERTING APPLICATION

Once the Supervisor has reviewed the full Application and Attachments, he/she can either revert the

Application back to the student if changes are required, or submit the Application to the Ethics Compliance

Officer. This is done via the ‘Action’ tab:

6.1 Reverting the Application

Action: Select the Action tab and click the Revert link.

Result: Confirmation Message is displayed.

The Status of the application will now change to PS Update Required. The Application has been sent back to

the student so that they can make the necessary amendments.

6.2 Submitting the Application

Action: Select the Action tab and click the Submit link.

Result: Loading page is displayed.

The Status of the application will now change to Exempt or ECO Review.


7.0 EMAIL NOTIFICATIONS

Emails will be sent to the Applicant, all Investigators and Supervisors listed on the Application whenever the

status of the Application changes. Emails are also sent to the ECO and the Committee Review Group when

their action is required.

8.0 AMENDING AN APPROVED APPLICATION

Amendment requests are submitted and reviewed outside of the Online System. You need to review the question “I need

to deviate from the approved application – how do I tell HREC?” available here:

https://i.unisa.edu.au/staff/research/research-ethics/human-research-ethics/ethics-management-for-approved-projects/

9.0 TROUBLESHOOTING

If you are having trouble logging into the System or completing the form, please contact the Research Ethics &

Integrity Team: email [email protected], ph. 8302 6330.

If you require ethics advice or guidance, please contact the relevant Research Ethics Advisor: see

https://mymailunisaedu.sharepoint.com/teams/rch/ris/risethics/Pages/rea.aspx (login required).

https://i.unisa.edu.au/staff/research/research-ethics/human-research-ethics/ethics-management-for-approved-projects/

mailto:[email protected]

https://mymailunisaedu.sharepoint.com/teams/rch/ris/risethics/Pages/rea.aspx


APPENDIX

APPLICATION STATUS

Term Definition

Approved The Committee Review Group has reviewed the Application and is

satisfied that the project meets the requirements of the National

Statement. The Applicant is free to commence the research as outlined

in the Application.

Approved Subject To The Application has been reviewed by a Committee Review Group and

returned to the Applicant with the review outcome “Approved Subject

To”. The Applicant is required to make minor changes to the

Application before resubmitting it for review.

Draft An Applicant has started an Application. It has not yet been submitted.

E1 – HREC Chair The Ethics and Compliance Officer has forwarded the Application for

review. At the time the Application was submitted, the System

determined that the research project does not pose a foreseeable risk

of harm or discomfort, and any foreseeable risk is no more than

inconvenience. The Applicant was thus notified that the risk associated

with the project requires E1 level of review. The Application is

forwarded to the Chair or Deputy Chair or HREC for E1 review.

The Chair or Deputy Chair of HREC review E1 Applications within 10

working days of receiving the application from the ECO (Ethics

Compliance Officer).

E2 – Committee Group Review The Ethics and Compliance Officer has forwarded the Application for


determined that the research project poses only one potential

foreseeable risk, that of discomfort. The Applicant was thus notified that

the risk associated with the project requires E2 level of review. The

Application is forwarded to a panel comprising 2 members: The Chair

or Deputy Chair of HREC and a Research Ethics Advisor.

The review panel reviews E2 Applications within 10 working days of

receiving the application from the ECO (Ethics Compliance Officer).

E3 - HREC The Ethics and Compliance Officer has forwarded the Application for


determined that the research project poses more than low risk. The

Applicant was thus notified that the risk associated with the project

requires E3 level of review.

HREC reviews E3 Applications at their next meeting, held approximately

every six weeks.

ECO Review An Applicant has completed an Application and has submitted it to the

Ethics and Compliance Officer, who conducts an initial check for

completeness and consistency.

ECO Update Required The Ethics and Compliance Officer has reviewed the Application and

requires the Applicant to provide additional information or amend

answers provided.


Exempt The Applicant has submitted an Application and the System has

determined that the research does not require further review as the

project is

EITHER

negligible risk (i.e., no foreseeable risk of harm or discomfort,

and any foreseeable risk is no more than inconvenience); and

involves the use of existing collections of data or records that

contain only non-identifiable data about human beings.

OR

conducted solely for the purpose of internal quality assurance

and will not be published or presented externally; or

conducted solely for the purpose of internal quality assurance,

and may be published externally only if the following criteria

are met:

the data was gathered online or in writing

the responses were provided voluntarily

the respondents were advised of the possibility that the data

could be used for such purposes; and

the anonymity of the respondents is maintained

Negligible Research projects in which there is no foreseeable risk of harm or

discomfort, and any foreseeable risk is no more than inconvenience (and

which are not exempt).

Not Approved The Committee Review Group has reviewed the Application and is not


Statement, nor that it can meet the requirements of the National

Statement if changes are made. The Application is “Not Approved” and

cannot be resubmitted.

Not Approved: Resubmit The Committee Review Group has reviewed the Application and is not


Statement. However, it could meet the requirements after significant

changes are made. The review outcome is “Not Approved: Resubmit”.

The Applicant is required to make significant changes to the Application

before resubmitting it for review.

PS Review An Applicant has completed an Application and submitted it for review

by their Principal Supervisor (PS).

PS Review – ECO Update Principal Supervisor to review changes made by the Applicant, in

response to the Ethics and Compliance Officer’s (ECO) comments.

PS Review – Review Update Principal Supervisor to review changes made by the Applicant, in

response to the Review Group’s comments (during E1, E2 or E3 review).

Withdrawn The Ethics and Compliance Officer has marked the Application as

withdrawn because the Applicant has advised them that the research

will not proceed, or the Application has been inactive for more than 6

months. It is not possible to ‘re-activate’ a withdrawn application.


COMMON TERMS

Term Definition

Committee Review Group Refers to one of three review groups that assess human research ethics

Applications. They are:

E1 – HREC Chair or Deputy Chair

E2 – Review Panel (HREC Chair/Deputy and a Research Ethics Advisor)

E3 – Review by full HREC

ECO Ethics and Compliance Officer

HREC Human Research Ethics Committee

REA Research Ethics Advisor

TOOLBAR

Icon Name Description

Next Page Go to the next page in the application

Previous Page Go to the previous page in the application

Action Drop-down menu that lists the possible actions for the

application, such as Withdraw, Submit, Delete

Save Save the application

Form Comments Comments that apply to the application overall

Page-level

Comments

Comments that apply to a specific page

Reports Reports menu to select and run a report. Reports include the

ability to print the whole application, application comments,

attached documents and review outcomes

Help Help for the page or for the questions

Exit Exit the application and return to the Applications home page


COMMENT FLAGS

Flag Description

Red A reviewer has entered an action comment on the page

Yellow

The applicant has responded to the action comment

Green

The reviewer has resolved the action comment

Blue

There is a general note on the page or application. This should be read, but no action is

required.

online ethics system principal supervisor user guide

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